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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-2248 | Other Identifier | WHO UTN Number | |
| HHSN261200800001E | Other Identifier | NIAID | |
| HHSN261201500003I | Other Identifier | NIAID |
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| Name | Class |
|---|---|
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Potential study patients will be any patients (both children and adults).
This study is an observational cohort to identify the etiologies of acute febrile illness (less than or equal to 2 weeks), which are thought to be endemic or novel in a certain area. Therefore, there are no hypotheses that require sample size calculation to be tested. It is expected that this study will enroll a minimum of 200 patients per site: approximately 100 adults and 100 pediatric cases. The final sample size is therefore estimated to be 1600.
Primary Objective:
To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes.
Secondary Objectives:
This study will be conducted at all the INA-RESPOND hospitals (8 hospitals):
The study will enroll eligible fever patients for a period of up to 1 year. Follow-up may be up until one year after last subject is enrolled. Stored samples will be investigated during the study and/or after study completion.
After enrollment, patients will be seen at 14-28 days and at 3 months post enrollment. Patients will be seen every 3 months (6, 9, and 12 months within a window period of +/- 14 days) until cured and no related symptoms persists or the one year time point is reached. The samples will be collected for storage at enrollment, the 14-28 day visit, at 3 months and every 3 months thereafter if not cured.
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| Measure | Description | Time Frame |
|---|---|---|
| The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular. | Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Affected Organ System by Each Specific Pathogen | The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen. | 3 years |
| Number of Participants Enrolled Per Each Clinical Research Site |
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Inclusion Criteria:
Exclusion Criteria:
Examples include, but not limited to: mental illness which could affect compliance with protocol, an anemic patient preventing blood draw.
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Hospitalized patients with acute febrile illness.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI | University of Diponegoro/ Dr. Kariadi hospital | Principal Investigator |
| Prof. Emiliana Tjitra, MSC, Ph.D | NIHRD, Indonesia | Principal Investigator |
| Dr. Bachti Alisjahbana, PhD, SpPD-KPTI | Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Udayana/Sanglah Hospital | Denpasar | Bali | 80114 | Indonesia | ||
| University of Diponegoro/ Dr. Kariadi Hospital |
No plan to share data
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From total target 1600 subjects only achieved 1492 subjects enrolled.
Recruitment period was done from July 2013 until October 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Hospitalized Participants With Acute Febrile Illness. | Hospitalized patients with any infectious diseases with cardinal symptoms at acute fever (<= 2 weeks) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
We analyzed all subjects enrolled and excluded 6 participants who were not eligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hospitalized Participants With Acute Febrile Illness | Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (<= 2 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular. | All participants who have specimens to be tested | Posted | Count of Participants | Participants | Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year. |
|
48 hours after study related blood drawn
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw that is possibly, probably, or definitely related to the blood draw. Any event outside of this 48 hour window period will not be considered an AE for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hospitalized Participants With Acute Febrile Illness | Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (<=2 weeks) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hematoma at the site where blood is drawn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Publication Division | INA-RESPOND | +62214208693 | inapublikasi@ina-respond.net |
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Plasma, buffy coat, urine, throat swab, nasal swab.
Eight clinical research sites in 7 cities in Indonesia have been established to conduct clinical research that improved research capacity and networking for Infectious diseases in Indonesia. |
| 3 years |
| Number of Vials Stored Based on Specimen Type | Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study. | 3 years |
| Semarang |
| Central Java |
| 50244 |
| Indonesia |
| University of Indonesia/ Dr. Cipto Mangunkusumo Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia |
| Penyakit Infeksi Sulianti Saroso Hospital | Jakarta | DKI Jakarta | 14340 | Indonesia |
| University of Airlangga/ Dr. Soetomo Hospital | Surabaya | East Java | 60286 | Indonesia |
| University of Padjajaran/ Dr. Hasan Sadikin Hospital | Bandung | West Java | 40161 | Indonesia |
| University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital | Makassar | 90245 | Indonesia |
| University of Gadjah Mada/ Dr. Sardjito Hospital | Yogyakarta | 55284 | Indonesia |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Affected Organ System by Each Specific Pathogen | The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen. | The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen. | Posted | Number | participants | 3 years |
|
|
|
| Secondary | Number of Participants Enrolled Per Each Clinical Research Site | Eight clinical research sites in 7 cities in Indonesia have been established to conduct clinical research that improved research capacity and networking for Infectious diseases in Indonesia. | Eight clinical research sites in 7 cities in Indonesia have been established to conduct clinical research that improved research capacity and networking for Infectious diseases in Indonesia. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Vials Stored Based on Specimen Type | Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study. | Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study. | Posted | Number | vials | 3 years | vials | vials |
|
|
|
| 89 |
| 1,486 |
| 0 |
| 1,486 |
| 8 |
| 1,486 |
|
| Fever | General disorders | Non-systematic Assessment | Fever, chills, sweating |
|
| Convulsion | Nervous system disorders | Non-systematic Assessment | Convulsion |
|
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| Salmonella spp. |
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| Rickettsia spp. |
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| Influenza |
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| Leptospira spp. |
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| Chikungunya |
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| E.Coli |
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| S. pneumoniae |
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| M. tuberculosis |
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| Multiple pathogens |
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| Other single pathogen |
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| Title | Measurements |
|---|---|
|
| RSPI Prof Dr Sulianti Saroso |
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| RSUP dr Wahidin Sudirohusodo |
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| RSUP dr Kariadi |
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| RSUD dr Soetomo |
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| RSUP dr Sardjito |
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| Title | Measurements |
|---|---|
|
| Pleural fluid |
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| Feces |
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| Nasopharyngeal swab |
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| Urine |
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| LCS |
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| Pus |
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| DNA |
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| RNA |
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